Introduction and Overview Our objective in this study is to evaluate the possible unintended consequences ofthe FDA decision to issue a warning regarding the prescribing of SSRIs to children and adolescents and require a BBW on antidepressant labels. Depression is prevalent among youth in the US and is a risk factor for suicide.(21) Thus, it is of critical importance that the public health implications of possible decreases in antidepressant treatment rates be fully understood. While much research has been conducted in this area, suboptimal study design, absence of long-term trend data, and/or lack of statistical power have left important questions about the effects ofthe warnings on suicidality unanswered. Below we review the important studies to date and highlight how our proposed research will fill gaps in our understanding ofthe relationships among FDA warnings (and associated media reports), antidepressant treatment in youth, and risk of suicidal behavior.